Thyroid Cancer, Relapse
Conditions
Keywords
recurrence Thyroid cancer, 18F-FDG PET-CT, diffusion-weighted Magnetic Resonance Imaging
Brief summary
The purpose of the study is to evaluate the concordance between the 18F-PET/CT under thyrotropin stimulation and the diffusion-weighted Magnetic Resonance Imaging, in the detection of residual mass in 40 patients with partial response or relapsed differentiated thyroid carcinoma.
Detailed description
The schedule and the procedures of the study are the following ones : * Baseline evaluation : * Clinical examination with neck echography after rhTSH stimulation * Normal whole body scan * First visit (inclusion): 18F-FDG PET/CT DW-MRI of the neck if possible performed shortly after the PET CT or within following days * Following visits: at 6 months and 12 months * DW-MRI of the neck performed shortly after the PET CT or within following days. * Ultrasonography guided fine needle aspiration for cytology for detection of cervical metastases and identifying thyroglobuline in the needle washout fluid if needed and in case of positivity of either PET or DW-MRI exams. * Histological assessment of biopsies if performed
Interventions
DEVICEPET
A FDG PET scan and a diffusion-weighted Magnetic Resonance Imaging will be performed to compare the efficacy to diagnose relapse in thyroid carcinoma
DEVICEMRI imaging
Sponsors
Centre Henri Becquerel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, * Subjects must be 18 years of age or older, * Histologically confirmed papillary or follicular differentiated thyroid carcinoma with partial response or complete response, defined by * Thyroglobulin \> 2 μg/L under thyrotrophin stimulation, four months after at least two 131-I based treatments (3,7 GBq/100mCi or more if optimal conditions), * Negative extension assessment (total body bone scan, (3,7 GBq/100 mCi or more)), echography, CT scan ( neck, thorax, abdomen): no findings.. * Patient's Informed Consent form signed.
Exclusion criteria
* History of previous cancer within the least three years, * Performance Status \> 2, * Protected adults * Any medical, psychological, social or disabling conditions that could interfere or jeopardize the patient's participation * History of allergy to radio-iodine, * Estimated GFR \< 45 ml/min /m² (MDRD method), * Women of childbearing potential without contraceptive method, * Uncontrolled diabetes mellitus, * Hypersensitivity to FDG or to any radio-tracers, * Contraindication to administration of Thyrogen® 0.9mg * Intraocular foreign bodies or any metallic foreign bodies that contraindicates the MRI. * Vascular clips, any object or implanted device that could interact with the ferromagnetic field, * Coronary and peripheral clips, aortic stent grafts, prosthetic heart valves, annuloplasty rings, vena cava filters, cardiac pacemaker, implantable cardiovascular defibrillators...., * Implanted insulin infuser * Neurostimulator device * Claustrophobia * Agitation or psychological trouble
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Report of positive or negative results of detection of recurrent lesions from both dw-MRI and 18F-FDG PET/CT. data will be reported extensively and descriptively. | 1 year | To assess concordance between FDG PET-CT scan and MRI in detection of cervical residual masses in 40 patients in Partial Response or in relapse cervical well-differentiated thyroid carcinoma |
Countries
France
Outcome results
None listed